FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11977–12000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K223132 · HQF
Iridex Corporation
Ophthalmic · 37d
Cleared Nov 08, 2022
Oxyfit Pulse Oximeter
K203812 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 680d
Cleared Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
K210346 · GKZ
Sysmex America, Inc.
Hematology · 638d
Cleared Nov 08, 2022
EFAI ChestSuite XR Pneumothorax Assessment System
K221552 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 161d
Cleared Nov 08, 2022
Hisense LCD monitor HMD2G21S, HMD3G21S
K222132 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 112d
Cleared Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 99d
Cleared Nov 08, 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · OCX
Diversatek Healthcare
Gastroenterology & Urology · 60d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY
Medtronic
Cardiovascular · 28d
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Nov 07, 2022
Lotus Prophy Angle
K220346 · EGS
Ajk Engineering, Inc.
Dental · 273d
Cleared Nov 07, 2022
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 258d
Cleared Nov 07, 2022
Smooth Drive contra angle and straight handpieces
K220874 · EGS
Lares Research
Dental · 227d
Cleared Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 137d
Cleared Nov 07, 2022
Vericor Support Catheter
K222679 · KRA
Vascupatent Medical (Shenzhen) Co., Ltd.
Cardiovascular · 62d
Cleared Nov 07, 2022
WaveForm A Interbody System
K222732 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 59d
Cleared Nov 07, 2022
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty...
K222741 · ELW
Hdi, Inc.
Dental · 59d
Cleared Nov 07, 2022
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M,...
K222800 · GEX
Sanhe Laserconn Tech Co., Ltd.
General & Plastic Surgery · 52d
Cleared Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve...
K222873 · DQY
Medtronic
Cardiovascular · 46d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · LZA
Safesource Direct, LLC
General Hospital · 45d
Cleared Nov 07, 2022
Humeris® 135 Shoulder System
K222936 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 42d
Cleared Nov 07, 2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
K223127 · DQK
Edwards Lifeciences, LLC
Cardiovascular · 35d
Cleared Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
K202755 · QDZ
Diasorin Molecular, LLC
Microbiology · 775d
Cleared Nov 04, 2022
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · DCK
Procise Diagnostics
Immunology · 907d
Cleared Nov 04, 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · FMF
Medwell Technology, Ltd.
General Hospital · 430d